Sr. Design Assurance Engineer
Job Description
The Sr. Design Assurance Engineer is a quality engineer who directly supports medical device product development from concept through commercialization.
This role involves working with cross-functional development teams to establish and maintain design control deliverables, risk management activities, and DHF compliance, ensuring the delivery of the highest quality product to the customer.
Responsibilities :
- Will be working with FDA regulations regarding design verification and validation planning.
- Will be performing risk management activities, design tests and inspection method development.
- Performing audit responses and product re-certifications, biocompatibility and sterilization support.
- Work with vendors, supplied component sampling plan development, and objective component specifications.
Qualifications :
- BS Industrial Engineering, Engineering or Business Degree
- 8-15 years of medical device experience in Quality Operations, or equivalent experience
- Must have FDA regulations knowledge within industry
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